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Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | Liposomal Bupivacaine use as active ingredient in the block |
|
| Control | Active Comparator | Ropivacaine use as active ingredient in the block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Inpatient post-operative stay after undergoing TKA procedure | Through entire inpatient hospital stay (lasted from 1 day to 1 week) |
| Inpatient Opioid Use | Opioid usage during their inpatient post-operative hospital stay | 1 week |
| Numeric Rating Scale (NRS) Pain Score Improvement | Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels. | 6 weeks |
| Outpatient Opioid Use | Opioid usage in the immediate post-operative period after hospital discharge | 6 weeks |
| WOMAC Score | Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period. | 6 weeks |
| Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chinenye Nwachuku, MD | St. Luke's Hospital and Health Network, Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
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Patients that presented to our outpatient Orthopaedic clinic and signed up to undergo a Total Knee Arthroplasty (TKA) were eligible for our study. No additional advertising was used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | Liposomal Bupivacaine use as active ingredient in the block Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
| FG001 | Control | Ropivacaine use as active ingredient in the block Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | Liposomal Bupivacaine use as active ingredient in the block Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | Inpatient post-operative stay after undergoing TKA procedure | Posted | Mean | Standard Deviation | Hours | Through entire inpatient hospital stay (lasted from 1 day to 1 week) |
|
17 months (June 2020-October 2021) Each patient was assessed for adverse events by direct history and physical exam by investigators at POD 0, POD 1, POD 2, POD 7, POD 14, POD 28, and POD 42.
Clinicaltrials.gov definitions will be used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exparel | Liposomal Bupivacaine use as active ingredient in the block Exparel: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | General disorders | Non-systematic Assessment |
Block efficacy is dependent on the performing anesthesiologist, with multiple performing anesthesiologists introducing variability that was not accounted for. The use of drains was surgeon specific rather than part of our study protocol. The state's online drug monitoring program reports narcotic prescriptions filled but not necessarily taken possibly pointing to a discrepancy. Finally, all patients were obtained from one demographic area, and all surgeries were only performed by two surgeons
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chinenye Nwachuku | Saint Luke's University Health Network | 6096101054 | chinenye.nwachuku@sluhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | May 12, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine |
|
Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery |
| 1 week |
Ropivacaine use as active ingredient in the block
Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| BMI | Mean | Full Range | kg/m^2 |
|
| American Society of Anesthesiology (ASA) Score | Determined by hospital Anesthesia team based on guidelines set forward by the American Society of Anesthesiologists ASA 1: A normal healthy patient. ASA 2: A patient with mild systemic disease. ASA 3: A patient with severe systemic disease. ASA 4: A patient with severe systemic disease that is a constant threat to life. ASA 5: A moribund patient who is not expected to survive without the operation. NOTE: Higher numbers are worse grades | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Kellgren and Lawrence Osteoarthritis Grade | K&L 0: No radiographic findings of osteoarthritis K&L 1: Doubtful narrowing of joint space and possible osteophytic lipping K&L 2: Definite osteophytes and possible narrowing of joint space K&L 3: Moderate multiple osteophytes, definite narrowing of joint space, small pseudocystic areas with sclerotic walls and possible deformity of bone contour K&L 4: Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour. NOTE: Higher grades denote more advanced arthritis. | Count of Participants | Participants |
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| Previous Surgery | Count of Participants | Participants |
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| Previous TKA | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Primary | Inpatient Opioid Use | Opioid usage during their inpatient post-operative hospital stay | Posted | Mean | Standard Deviation | Milimorphine Equivalents/Day | 1 week |
|
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|
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| Primary | Numeric Rating Scale (NRS) Pain Score Improvement | Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels. | Number of patients available in Post-operative day (POD) 2 lower secondary to earlier discharges. Number of patients available for analysis in in POD 7-42 time points secondary to their follow up). To account for this, both an "intention to treat" and a "per protocol" analysis were completed. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
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| Primary | Outpatient Opioid Use | Opioid usage in the immediate post-operative period after hospital discharge | Posted | Mean | Standard Deviation | Milimorphine Equivalents/Day | 6 weeks |
|
|
|
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| Primary | WOMAC Score | Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels. | Number of patients available for analysis in in POD 7-42 time points decreased secondary to their follow up. To account for this, both an "intention to treat" and a "per protocol" analysis were completed. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
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| Secondary | Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively | Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
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| Secondary | Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively | Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery | Posted | Count of Participants | Participants | 1 week |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control | Ropivacaine use as active ingredient in the block Ropivacaine: Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine | 0 | 50 | 0 | 50 | 4 | 50 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| 4 |
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| POD 1 |
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| POD 2 |
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| POD 7 |
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| POD 14 |
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| POD 28 |
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| POD 42 |
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| POD 7 Stiffness Subscore |
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| POD 7 Physical Function Subscore |
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| POD 7 Total Score |
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| POD 14 Pain Subscore |
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| POD 14 Stiffness Subscore |
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| POD 14 Physical Function Subscore |
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| POD 14 Total Score |
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| POD 28 Pain Subscore |
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| POD 28 Stiffness Subscore |
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| POD 28 Physical Function Subscore |
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| POD 28 Total Score |
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| POD 42 Pain Subscore |
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| POD 42 Stiffness Subscore |
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| POD 42 Physical Function Subscore |
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| POD 42 Total Score |
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